Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LM2216 | OT |
hyperthyroidism/Subclinical hyperthyroidism/abnormal thyroid labs; angina pectoris/chest pain; thyroid mass/thyroid nodules; thyroiditis subacute; blood pressure increased; swelling in her neck; blood thyroid stimulating hormone decreased; Tachycardia/palpitations; Tachycardia/palpitations; This is a spontaneous report received from a Physician from License Party. Other Case identifier(s): 2025SA335868 (Sanofi), AE-021888 (BioNTech SE). A 68-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Lot number: LM2216, Expiration Date: 10Mar2025) at the age of 67 years intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA), on 12Sep2024 as dose number unknown, single (Lot number: 48429CA, Expiration Date: 30Jun2025) intramuscular for immunisation. The patient's relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Rash" (ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM taken for hyperlipidaemia; VALSARTAN taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: FC3183; Expiry date: 21Oct2021), administration date: 05Sep2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot: FJ9943; Exp: 07May2022), administration date: 15Apr2022, when the patient was 66-year-old, for Covid-19 Immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE; Lot: Gj3277; Exp: 31Jul2023), administration date: 13Oct2022, when the patient was 66-year-old, for Covid-19 Immunization; COVID-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Lot: GH4664: Exp: 31Dec2023), administration date: 12Oct2023, when the patient was 67-year-old, for Covid-19 Immunization. The following information was reported: TACHYCARDIA (non-serious), PALPITATIONS (non-serious) all with onset 23Sep2024, outcome "recovering" and all described as "Tachycardia/palpitations"; BLOOD THYROID STIMULATING HORMONE DECREASED (non-serious) with onset 19Nov2024, outcome "recovering"; SWELLING (non-serious) with onset 19Nov2024, outcome "unknown", described as "swelling in her neck"; HYPERTHYROIDISM (medically significant), outcome "recovering", described as "hyperthyroidism/Subclinical hyperthyroidism/abnormal thyroid labs"; ANGINA PECTORIS (medically significant), outcome "recovered", described as "angina pectoris/chest pain"; THYROID MASS (non-serious), outcome "not recovered", described as "thyroid mass/thyroid nodules"; THYROIDITIS SUBACUTE (non-serious), outcome "recovering"; BLOOD PRESSURE INCREASED (non-serious), outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) increased; Blood thyroid stimulating hormone: (19Nov2024) 0.09, notes: Decreased; Free thyroxine index: (unspecified date) 1.6. Therapeutic measures were taken as a result of blood pressure increased. Clinical course: On 12Sep2024, the patient received a dose of 0.3 (units unspecified) of suspect Influenza Vaccine produced by unknown manufacturer. On 23Sep2024 the patient developed tachycardia/palpitations following the first dose intake and (unknown latency) following the last dose intake (LM2216 and expiry date on 10Mar2025) of Tozinameran. The patient was treated with Amlodipine besilate (amlodipine) for Blood pressure increased. Sanofi Comment: Sanofi company comment dated 18Nov2025: This case involves a 67 years old female patient who had subclinical hyperthyroidism/abnormal thyroid labs, angina/chest pain, subacute thyroiditis, elevated bp, tachycardia/palpitations, had a low tsh, swelling in her neck and thyroid nodules while receiving vaccine Influenza vaccine and while treated with tozinameran [comirnaty]. Further information regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: As there is limited information in the case provided, the causal association between the events hyperthyroidism, and angina pectoris and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Rash
Medical History/Concurrent Conditions: Hyperlipidaemia; Hypertension
ATORVASTATIN CALCIUM; VALSARTAN
Test Name: Blood pressure; Result Unstructured Data: Test Result:increased; Test Date: 20241119; Test Name: Blood thyroid stimulating hormone; Result Unstructured Data: Test Result:0.09; Comments: Decreased; Test Name: Free thyroxine index; Result Unstructured Data: Test Result:1.6